Kornimate/medical-research-clean huggingface dataset:
trastuzumab in a neo-adjuvant regimen for her2+ breast cancer - the train study

Conditions: Breast Cancer; HER2 Positive

Summary: to determine the activity of the combination of paclitaxel, trastuzumab and carboplatin as neo-adjuvant treatment in patients with stage ii or iii her2 positive breast cancer


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed infiltrating breast cancer. * stage ii or stage iii breast cancer.28 'locally advanced breast cancer' patients are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. n1 status must have been demonstrated by either fine needle aspiration from an axillary lymph node or by a metastasis of \>2 mm in diameter at sentinel node biopsy. stage iia patients are eligible if the tumor is \>3 cm in diameter or if the tumor is between 2 and 3 cm in diameter but a breast conserving surgery is not possible. * overexpression and/or amplification of her2 in an invasive component of the core biopsy, according to one of the following definitions: * \>10% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+) * \>10% of invasive tumor cells showing moderate complete circumferential membrane staining (score 2+) and demonstrating her2 gene amplification defined as a fish ratio of her2 gene copies to chromosome 17 signals of \>2.2. or as \>5 her2 gene copies per nucleus in cish analysis. patients with a negative or equivocal overall result (fish test ratio of \<2.2, \<6.0 her2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by ihc are not eligible for participation in the trial. * age ≥18 * eastern cooperative oncology group (ecog) performance status ≤1 (appendix b) * adequate bone marrow function (anc \>1.0 x 109/l, platelets \>100 x 109/l) * adequate hepatic function (alat, asat and bilirubin \<2 times upper limit of normal) * adequate renal function (creatinine clearance \>60 ml/min) * lvef ≥50% measured by echocardiography or muga * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * signed written informed consent exclusion criteria: * no previous radiation therapy or chemotherapy * no other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy. * no current pregnancy or breastfeeding. women of childbearing potential must use adequate contraceptive protection. * no evidence of distant metastases. staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. abnormal uptake on the isotope bone scan can only be accepted if mri, ct-scan, or plain radiograph excludes bone metastases. * no concurrent anti-cancer treatment or another investigational drug

Keywords: breast cancer her2 positive neo-adjuvant trastuzumab paclitaxel carboplatin
generate real world data on tofacitinib induction therapy and changes in clinical and patient reported outcomes.

Conditions: Ulcerative Colitis

Summary: this study is expected to contribute to the body of real-world data of tofacitinib's safety and efficacy profile in ulcerative colitis. conventional clinical outcomes will give a better understanding of response and remission rates in a representative, post-marketing population. regular patient questionnaires and measurement of a biomarker of gut inflammation will provide detail on how patients experience induction treatment and contextualise the efficacy data.

this is a low-interventional study in which the intervention under study is home fecal calprotectin testing which falls outside of normal standard of care in ulcerative colitis. tofacitinib is prescribed and administered as per the swiss prescribing information. accordingly, this study is registered on clinicaltrials.gov as an interventional study. under swiss law, this study is considered and approved as a non-interventional study (category a, human research ordinance, swiss confederation).

Eligibility criteria:
inclusion criteria: * male or female participants 18 years of age or older at screening visit * participants with confirmed diagnosis of uc and who are prescribed tofacitinib (xeljanz®) for moderately to severely active uc as per the swiss label * participants who are willing and able to comply with all scheduled visits, treatment plan, study interventions, and other study procedures * capable of giving personally signed informed consent exclusion criteria: * presence of clinical findings suggestive of crohn's disease * any previous exposure to tofacitinib including participation in the tofacitinib clinical program * co-medication with any other advanced therapies for uc (biologics\*, azathioprine, mercaptopurine and methotrexate) or any other jak inhibitor * any identified contra-indications for use of tofacitinib as per the swiss label * not owning a handheld digital device compatible with the sidekick health app, not willing to have it installed on this device or not capable of using the app * investigator site staff or pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries.

Conditions: Postoperative Pain

Summary: efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries.

postoperative pain is one of the commonest feared surgical side effect which can lead to patient dissatisfaction. it occurs due to a combination of inflammatory reaction and an injury to neural tissue caused by the surgical incision. anterior nasal packing is not an innocuous procedure. it causes discomfort/pain (especially upon removal), nasal mucosa trauma, epiphora, local infection, discomfort in swallowing, sleep disturbances and, very rarely, toxic shock and vagal reflex. although systemic opioids are traditionally used in the management of postoperative pain, their use is still limited by their possible side effects. opioid drugs mimic the actions of the endogenous opioid peptides by interacting with specific receptors, the opioid receptors which are μ, δ and κ. the μ receptor is important in sensory processing, including the modulation of nociceptive stimuli, extrapyramidal functioning and in limbic and neuroendrocine regulation. there are two subtypes of the μ receptor, a high-affinity μ receptor and a low-affinity μ2 receptor. recently a third μ subtype has been described that binds opioid alkaloids such as morphine, but has essentially no, or exceedingly low, affinity for the naturally occurring endogenous opioid peptides or non-alkaloid opioids such as fentanyl. based on the hypothesis that mu (μ) opioid receptor expression increases at the site of inflammation. our study aims to assess the analgesic effect produced by local application of fentanyl through fentanyl soaked nasal packs following different nasal surgeries.

Eligibility criteria:
inclusion criteria: 1. patients undergoing nasal surgeries requiring bilateral nasal packs. 2. patients 18 years or older. exclusion criteria: 1. patients in whom fentany is contraindicated such as respiratory comorbidites (copd and asthma), hypersensitivity to fentanyl, liver diseases or had previous biliary tract surgeries 2. systemic medical problems interfering with surgery. 3. patients with traumatic conditions e.g fracture face or fracture nasal bone. 4. patients who refuse to take part in the study. 5. patients with different nasal pathology in both sides e.g if partial turbinectomy is indicated in one side of the nose or patients with unilateral nasal polyp.
infraorbital nerve involvement on magnetic resonance imaging in european patients with igg4-related ophthalmic disease

Conditions: Orbital Inflammation

Summary: systematic medical chart and imaging files review of patients presenting with non-lymphoma, non-thyroid-related orbital inflammation. the review aims at comparing the frequency of mri infra-orbital nerve enlargement, between patients diagnosed with an igg4-related ophthalmic disease (igg4-rod) and other patients.


Eligibility criteria:
inclusion criteria: * patient suffering from acute orbital inflammation exclusion criteria: * thyroid disease * lymphoma
hiv-1 non-group m in cameroon : study of genotypic and phylogenetic diversity (obsocam)

Conditions: HIV Infection

Summary: the aim of the study is to study the genotypic characteristics of hiv-1 non-m circulating in the whole cameroon and their genetic evolution.

hiv-1 is divided four distinct groups: m (major) which represents the pandemic strains while others groups o (outlier), n (non m, non o) and p are called non-m variants. group o (hiv-o) is more divergent, endemic in central africa and cameroon, where it represents about 1% of hiv infections. these variants are characterized by an important genetic divergence from pandemic hiv-1 group m (hiv-m), which impacts on the diagnosis, monitoring and treatment of infected patients. although discovered in 1990, and emerged at the same time as hiv-m, no data of epidemiology, natural history and evolution of the genetic diversity of these variants is currently available. the few knowledge available to date come from sporadic cases, mainly through studies in yaoundé. it is therefore essential to improve current knowledge on these variants and their consequences on infected patients. the aim of the study is to study the genotypic characteristics of hiv-1 non-m circulating in the whole cameroon and their genetic evolution.

Eligibility criteria:
inclusion criteria: * all available samples tested positive for hiv during the national health survey of cameroon in 2011 and 2018 * all individuals who came to centre pasteur in yaoundé or garoua for hiv screening or viral load monitoring. exclusion criteria: * insufficient quantity or degraded dried blood spot samples * all hiv-positive individuals aged less than 21 years, infected with a group m hiv-1 virus, or those who refused to participate in the study

Keywords: hiv genetic diversity hiv-1 non-m variants
national tunisian registry of cardiac implantable electronic devices

Conditions: Cardiac Implantable Electronic Devices

Summary: the national tunisian registry of cardiac implantable electronic devices is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of cardiac implantable electronic devices in tunisia. cardiologists from both sectors (public and private) are participating in the study, with 26 investigational centers. data is captured electronically by dacima clinical suite, according to fda 21 cfr part 11 (food and drug administration 21 code of federal regulations part 11), hipaa (health insurance portability and accountability act) \& ich (international conference on harmonisation) requirements.


Eligibility criteria:
inclusion criteria: * patients originated from tunisia * signed informed consent * patients undergoing a cardiac implantable electronic device procedure exclusion criteria: * informed consent not given

Keywords: cardiac implantable electronic devices heart pacemaker implantable cardioverter defibrillator cardiac loop recorders biventricular pacemakers heart rhythm disorder
outcomes after esophagectomy with a focus on minimally invasive esophagectomy and quality of life

Conditions: Esophagectomy; Esophageal Cancer

Summary: to assess short and long term outcomes after minimally invasive esophagectomy compared to open esophagectomy. to compare both standard outcome measures as well as patient derived outcome measures, in particular, quality of life (qol). to look at the applicability of this qol instrument to this patient group.

assess short and long term outcomes after minimally invasive esophagectomy(mie) compared to open esophagectomy. measure standard observer derived outcomes such as morbidity, mortality, tumor recurrence and also patient derived outcomes, in particular quality of life (qol) using the mos sf36 questionnaire. evaluate whether the sf36 will accurately reflect pre and postoperative changes in clinical status in this patient group.compare the results of this global qol instrument (sf 36) to disease specific scales of dysphagia and reflux. assess the impact of adjuvant or neoadjuvant therapy on qol in this patient group and determine if any advantages of mie can be demonstrated.

Eligibility criteria:
inclusion criteria: * patients scheduled for mie (minimally invasive esophagectomy) * patients scheduled for open esophagectomy * signed informed consent exclusion criteria: * patients who are unable to comprehend or complete the qol instruments. * patients less than 18 years of age.

Keywords: esophagectomy esophageal cancer quality of life minimally invasive esophagectomy laparoscopic transhiatal esophagectomy open esophagectomy karnofsky score dysphagia score heartburn scale nutrition score
study to investigate efficacy and safety of adalimumab in japanese subjects with generalized pustular psoriasis (gpp)

Conditions: Generalized Pustular Psoriasis (GPP); Adalimumab; Japanese

Summary: the purpose of this study was to investigate the efficacy, safety, and pharmacokinetics of adalimumab in japanese participants with generalized pustular psoriasis (gpp) who did not have an adequate response to their currently approved treatment.

this was a phase 3, multicenter, open-label, single-arm study of adalimumab in japanese participants with generalized pustular psoriasis (gpp). the study included a 30-day screening period, a 52-week treatment period, and a 70-day follow-up period. the dose regimen of adalimumab used in this study was 80 mg at week 0 by subcutaneous (sc) injection, followed by 40 mg every other week (eow) on and after week 2 until week 50. dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after week 8.

Eligibility criteria:
inclusion criteria: * diagnosis of generalized pustular psoriasis * total skin score of at least 3 and erythema with pustules (skin score of at least 1) at baseline in the japan dermatology association (jda) severity index of generalized pustular psoriasis (gpp) in gpp medical care guideline 2014 in japan * inadequate response to, or intolerance to, or contraindication to the currently approved gpp treatment (excluding infliximab) * infliximab secondary failure, or intolerant to infliximab exclusion criteria: * erythrodermic psoriasis, guttate psoriasis or sub-corneal pustular dermatosis at screening * drug-induced gpp * cannot stop ongoing use of prohibited gpp treatments * total jda severity index of gpp of 14 or more in gpp medical care guideline 2014 in japan

Keywords: efficacy safety
pulmonary vein ablation of atrial fibrillation using magnetic navigation: single ring versus circumferential techniques

Conditions: Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation

Summary: the single-ring ablation method aims for isolation of the posterior la wall including the pulmonary veins. if avoiding ablation on the posterior la wall esophageal injury is unlikely. aim of this prospective study was to evaluate the safety and efficacy of an rmn-guided single-ring ablation method as compared to standard rmn-guided circumferential pva.


Eligibility criteria:
inclusion criteria: * drug refractory af patients undergoing pva exclusion criteria: * drug refractory af patients undergoing repeat pva
efficacy & safety of single dose alprostadil cream (2 concentrations enhancer) to vehicle in men w/erectile dysfunction

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to assess the safety \& efficacy of a single dose of alprostadil cream with 2 concentrations of wc3036 compared to vehicle alone in men with erectile dysfunction.


Eligibility criteria:
inclusion criteria: * male subject aged 40 or older of any race * history of ed (erectile dysfunction) of at least 3 months duration defined as inability to attain \& maintain an erection of the penis sufficient to permit satisfactory sexual intercourse * completed and signed informed consent prior to any study related procedures exclusion criteria: * history/presence any significant disease that investigator feels will interfere with course of the study * anatomic deformity of penis * history/presence alcoholism or drug abuse/dependence within past 2 years (discretion of investigator) * participation in investigational study drug trial within 30 days prior to randomization
immunoglobulin g4 and immunoglobulin e antibodies in a population with adverse reactions to foodstuffs-related symptoms

Conditions: Immunoglobulin E-Mediated Food Allergy; Immunoglobulin G4-Related Disease; Symptoms and Signs; Adverse Reaction to Food

Summary: the aim of this study is to analyze a population with symptoms associated with adverse reactions to foodstuffs (arfs). to determine the levels of food-specific immunoglobulin g4 (igg4) and immunoglobulin e (ige) antibody reactions (abr).

volunteers with symptoms related with adverse reactions to foodstuffs (arfs) and suspicion of having a food allergy or a food intolerance are enrolled in this study. a 50μl of capillary whole blood is analyzed and the levels of food-specific immunoglobulin g4 (igg4) or immunoglobulin e (ige) antibody reactions (abr) are determined.

Eligibility criteria:
inclusion criteria: * adults (\>18 years of age) * to present symptoms related to adverse reactions to foodstuffs (arfs) exclusion criteria: * antibiotic treatment
comparison between two revascularization strategies in mvd patients with uncomplicated st-elevation mi

Conditions: STEMI

Summary: the study aimed to compare major adverse cardiac and cerebrovascular events(macce) and mortality at one year between two strategies: complete revascularization including non-culprit lesions percutaneous coronary intervention(pci) during primary pci(ppci) versus complete revascularisation during the same hospital admission in multi-vascular coronary artery disease(mvd) patients presenting with st-elevation myocardial infarction(stemi) uncomplicated by cardiogenic shock.

complete revascularisation in mvd patients with stemi uncomplicated by cardiogenic shock has been shown to improve outcomes, however the optimal timing of treatment of the non-culprit lesions is not known. the 2018 esc/eacts guidelines on myocardial revascularization states that "routine revascularization of non-ira (infarct related artery) lesions should be considered in patients with multivessel disease before hospital discharge". our trial showed that among the fore mentioned patients there was no difference regarding outcomes when using a strategy of complete revascularization with non-culprit lesions pci during ppci or during the same hospital admission.

Eligibility criteria:
inclusion criteria: 1. men and women with successful pci (preferably using a drug-eluting stent) to the culprit lesion for stemi ( pci for stemi should be primary pci in the first 12 hours after symptom onset) and complete revascularization of non-culprit lesions during the index ppci procedure or during a different procedure performed before index hospital discharge. 2. multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary pci and that is amenable to successful treatment with pci and has: * at least 75% diameter stenosis (visual estimation) or * at least 50% diameter stenosis (visual estimation) with fractional flow reserve (ffr) ≤ 0.80 3. age between 18 and 90 years 4. written informed consent could be obtained from all the patients exclusion criteria: 1. rescue pci for failed fibrinolysis or a combination strategy where pci is performed routinely 3-12 hours after fibrinolysis 2. cardiogenic shock 3. non-cardiovascular known co-morbidity reducing life expectancy to \< 2 years 4. any factor precluding 1year follow-up 5. prior coronary artery bypass graft (cabg) surgery 6. a different operator from the previously designated 7. unable to provide consent for any other reason

Keywords: ppci, multivessel coronary artery disease, stemi
a safety, pharmacokinetic and pharmacodynamic study of acp-001 (transcon hgh) in adults with growth hormone deficiency

Conditions: Adult Growth Hormone Deficiency

Summary: this study investigates the safety, tolerability, pharmacokinetic profile (pk), and pharmacodynamic response (pd) of three different doses of acp-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administrations) in adults with growth hormone deficiency.


Eligibility criteria:
inclusion criteria: * male or female between 20 to 70 years * body mass index (bmi, kg/m2) of 19.0 to 36.0 kg/m2, both inclusive * adult growth hormone deficient (ahgd) patients with documented growth hormone deficiency as defined in the consensus guidelines for the diagnosis and treatment of adults with gh deficiency ii (consensus guidelines 1998 and 2007) * fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion * gh replacement therapy for at least 3 months * willing to maintain current activity level during the trial * subjects are able and willing to provide written informed consent and authorization for protected health information disclosure in accordance with good clinical practice (gcp) exclusion criteria: * history of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study. * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. reliable methods for women are orally administered hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (iud) and sexual abstinence. * active malignant disease or malignant disease within the last 5 years * proliferative retinopathy judged by retina-photo within the last year * heart insufficiency as judged by the investigator and/or nyha 3 or greater (nyha criteria for diagnosis of diseases of the heart, 1994) * subjects with uncontrolled diabetes with an hba1c above 8.0% and/or insulin treatment * stable pituitary hormone replacement therapy for less than 3 months * impaired liver function as judged by the investigator or hepatic transaminases \> 2 times the upper limit of normal * impaired kidney function as judged by the investigator and/or creatinine clearance \ 1.4 mg/dl * participation in another interventional clinical study involving an investigational compound within 3 months prior to enrolment in this study or participation in another interventional clinical study involving an investigational compound during this study. * subjects who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study. * history or presence of alcohol abuse or drug abuse. * patients with known history for, or presence of, anti-hgh and / or anti-peg antibodies